(44 days)
The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows: Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
The ICONN Answer II Suture Anchor (P/N's 147501 and 155001) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-600L polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in two sizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.
The provided text is a 510(k) summary for the ICONN Answer II Suture Anchor, a medical device. It describes performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about studies involving AI or human readers for diagnostic purposes.
Therefore, I cannot fulfill your request for information related to:
- A study proving the device meets acceptance criteria using an AI system.
- Number of experts establishing ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Sample size and ground truth for training set.
The document focuses on mechanical and biocompatibility testing for a physical medical device (suture anchor), not a diagnostic AI system.
Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and performance, as appropriate for a physical implantable device:
Description of Device Testing and Acceptance Criteria
The ICONN Answer II Suture Anchor underwent performance testing to demonstrate its safety and effectiveness, and substantial equivalence to its predicate device (Arthrex PEEK Corkscrew FT (K061665)). The tests focused on mechanical properties, biocompatibility, and sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Anchor displacement after cyclic loading | Performance similar or better than predicate, or within acceptable ranges. (Guidance from FDA's Draft Guidance Document for Testing Bone Anchor Devices, April 20, 1996) | Performed similarly or better than the predicates or within acceptable ranges for the intended use. |
| Ultimate anchor pull-out | Performance similar or better than predicate, or within acceptable ranges. (Guidance from FDA's Draft Guidance Document for Testing Bone Anchor Devices, April 20, 1996) | Performed similarly or better than the predicates or within acceptable ranges for the intended use. | |
| Torsional properties (Insertion Testing) | Demonstrate device can be safely implanted. (Followed ASTM F543-2013, section A1) | Analyzed and compared to demonstrate the device can be safely implanted. | |
| Driving torque (Insertion Testing) | Demonstrate device can be safely implanted. (Followed ASTM F543-2013, section A2) | Analyzed and compared to demonstrate the device can be safely implanted. | |
| Biocompatibility Testing | Cytotoxicity | Cytotoxicity score of 2 or less (in accordance with ISO 10993/(R)2013). | All test articles resulted in a cytotoxicity score of zero (0). |
| Irritation (SC extract) | Score difference of 0.2 or less (in accordance with ISO 10993/(R)2013). | Score difference of 0.0. | |
| Irritation (SO extract) | Score difference of 0.2 or less (in accordance with ISO 10993/(R)2013). | Score difference of 0.1. | |
| Sensitization | No evidence of causing delayed dermal contact sensitization (in accordance with ISO 10993/(R)2013). | No evidence of causing delayed dermal contact sensitization. | |
| LAL testing (Endotoxin) |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.